1. Clinical Guidelines for Immunoglobulin Use Welcome Denise O’Shaughnessy

2. Clinical Guidelines for Immunoglobulin Use Overview of changes Aidan McManus

4. OUTLINE Where are the guidelines? Major changes to guidelines Minor changes to guidelines

5. Where are the guidelines?

6. www.dh.gov.uk/en/Publicationsandstatis tics/Publications/PublicationsPolicyAndG uidance/DH_129617 DH_129617

7. Audio slide presentations online www.ivig.nhs.uk

8. Second edition update 2008 2011

9. Second edition update 2008 2011

10. Second edition update Major changes 1.Selection criteria for appropriate use of immunoglobulin 2.Efficacy outcomes to assess treatment success 3.Modification of existing indications and inclusion of new indications

11. Haemophagocytic lymphohistiocytosis – 2008

12. Total Grams Infused for Haematology Q1 2010 DiagnosisGrams Used% Of Total Idiopathic thrombocytopenic purpura - adult 31111.555.17% Other (Haematology) 982017.41% Autoimmune thrombocytopenia (see ITP) 679512.05% Autoimmune haemolytic anaemia 27354.85% Alloimmune thrombocytopenia - fetal therapy (treatment to the mother) 26654.73% Idiopathic thrombocytopenic purpura ( >16 years) 9601.70% Haemophagocytic lymphohistiocytosis/haemophagocytic syndrome 6211.10% Acquired von Willebrand disease 4870.86% Post-transfusion hyperhaemolysis (usually in patients with sickle cell disease) 3000.53% Acquired red cell aplasia due to parvovirus B19 2850.51% Other (Other) 2300.41% Evans' syndrome 1100.20% Adult HIV-associated thrombocytopenia 1050.19% Primary immunodeficiencies - Hypogammaglobulinaemia 600.11% Systemic lupus erythematosus with secondary immunocytopenias 500.09% Haemolytic uraemic syndrome 37.50.07% Alloimmune thrombocytopenia - neonatal therapy 12.50.02% Haemolytic disease of the fetus and newborn (isoimmune haemolytic jaundice in neonates) 100.02%

13. Australian guideline

14. Haemophagocytic lymphohistiocytosis – 2011

15. Second edition update 1.Selection criteria for appropriate use of immunoglobulin 2.Efficacy outcomes to assess treatment success 3.Modification of existing indications and inclusion of new indications

16. Australian guideline

17. Haemophagocytic lymphohistiocytosis – 2011

18. Australian guideline

19. “The update specifies the outcome(s) measures, but not the degree in improvement of outcome(s) required to constitute treatment success” Commissioners will work with expert clinicians to refine these outcomes to provide defined ‘treatment success’ measures where possible. Efficacy monitoring

20. Second edition update 1.Selection criteria for appropriate use of immunoglobulin 2.Efficacy outcomes to assess treatment success 3.Modification of existing indications and inclusion of new indications

21. Immunoglobulin use in haematology 2010 database report

22. Grouping of diseases under single headings

23. Changes to the colour-coded prioritisation in the Demand Management Programme Grey to Blue The database review identified two of the top 10 immunoglobulin-using indications as Grey (secondary antibody deficiencies and antibody-mediated rejection following solid organ transplantation). In the previous edition, they were listed under immunosuppressive pharmacotherapy, and separately under some of the haematological malignancies such as CLL, without listing other mature B-cell malignancies such as non-Hodgkin’s lymphoma. These have been revised into a single indication. Antibody-mediated rejection following solid organ transplantation and antibody-incompatible transplantation were reviewed, and a single grouping of ‘Transplantation (solid organ)’ has been introduced and listed as Blue.

24. Changes to the colour-coded prioritisation in the Demand Management Programme Grey to Blue Acquired von Willebrand disease has now been included with acquired haemophilia, in the general disease grouping of ‘Coagulation factor inhibitors’. Polymyositis and Inclusion body myositis have now been grouped with dermatomyositis under the general disease grouping of inflammatory myopathies, with strict selection criteria. Post-transfusion hyperhaemolysis has now been grouped under the more general heading of haemolytic anaemia. SLE with secondary immunocytopenias should be considered under the relevant immune cytopenia.

25. Changes to the colour-coded prioritisation in the Demand Management Programme Blue to Red Specific antibody deficiency, as a recognised primary antibody deficiency disorder, has been reclassified as a Red indication (for those cases where immunoglobulin replacement therapy is required). Haemolytic disease of the newborn has been updated to reflect recommendations in ‘NICE clinical guideline 98’ on neonatal jaundice.

26. Second edition update Minor changes 1.Definitions of duration of immunoglobulin treatment 2.Recommended dosing of immunoglobulin 3.Ideal body weight-adjusted dosing of immunoglobulin

27. Definitions of duration of immunoglobulin treatment

28. Recommended dosing of immunoglobulin

29. Ideal body weight-adjusted dosing of immunoglobulin

30. Database update will reflect advice and updated terminology